Quality Engineer

Quality EngineerThe Quality Engineer plays a key role in ensuring robust manufacturing quality and regulatory compliance in an electronics and medical device environment. Approximately 60% of the role focuses on technical activities such as audit preparation, root cause analysis (RCA), corrective and preventive actions (CAPA), first pass yield improvement, and continuous improvement initiatives. The remaining 40% is more strategic, involving data analysis, quality management system (QMS) audits, and validation activities to drive long-term quality performance and process excellence.Responsibilities:Oversee in-process quality controls and day-to-day quality performance in manufacturing, including metrics such as defects per million opportunities (DPMO), material review board (MRB) activities, and continuous improvement using systematic approaches.Remain readily available on the manufacturing floor to resolve real-time quality issues and support production teams in maintaining high-quality output.Manage the complaint and nonconformance (NCR) database and address customer-issued supplier corrective action requests (SCARs) in a timely and thorough manner.Perform product and process qualifications based on customer requirements, ensuring compliance with relevant standards and specifications.Support the new product introduction (NPI) process for new products, contributing to quality planning, risk assessment, and validation activities.Develop customer-specific quality plans that align with contractual requirements, regulatory expectations, and internal quality standards.Support the Site Quality Leader in regulatory, customer, and internal audits by preparing documentation, participating in audit activities, and implementing follow-up actions.Execute the internal quality audit program and ensure findings are documented, communicated, and closed through effective corrective and preventive actions.Lead and train cross-functional teams to perform layered process audits, promoting a culture of accountability and continuous improvement.Assist the Site Quality Leader in maintaining and improving the QMS, ensuring procedures, work instructions, and records remain current and effective.Ensure conformance to quality and environmental certifications and standards, such as ISO and IPC, by monitoring compliance and supporting related initiatives.Coordinate with the Regional Supplier Quality Engineer to resolve supplier performance issues, including quality defects, delivery concerns, and process nonconformances.Support training needs by providing guidance and coaching to quality and production team members on quality tools, standards, and best practices.Coordinate and conduct frequent cell-level layered process audits with quality engineering personnel and other site functional leaders to verify process adherence and effectiveness.Assist with regional and site quality initiative projects, contributing technical expertise and data-driven insights.Support and assist other Quality Engineers in customer-focused teams to address systemic issues and drive effective CAPA resolution.Manage and collect systemic data for process improvement, using analytical tools to identify trends, root causes, and opportunities for optimization.Maintain up-to-date knowledge of quality and regulatory changes applicable to the manufacturing site and communicate relevant updates to stakeholders.Keep the Site Quality Leader fully informed of significant occurrences and trends that impact process quality, quality systems, or supplier quality operations.Drive continuous improvement and first pass yield enhancement through structured methodologies such as Kaizen and other CI efforts.Prepare for and participate in customer, regulatory, and third-party audits, ensuring readiness of documentation, processes, and personnel.Essential Skills:Bachelor's degree in Quality, Engineering, or equivalent industry and/or military experience.Up to 4 years of experience in quality or related roles, preferably within electronics manufacturing services or a related contract manufacturing environment.Hands-on experience in electronics manufacturing, particularly PCB and PCBA assembly.Background in medical devices and familiarity with associated regulatory and quality requirements.Experience working in quality for an organization certified to ISO standards, with ISO 9001 experience preferred.Proven experience with audits, root cause analysis (RCA), and corrective and preventive actions (CAPA).Knowledge of AS9100 requirements and their application in manufacturing quality systems.Familiarity with IQ, OQ, and PQ qualification processes for equipment and processes.Basic knowledge and understanding of Lean and Six Sigma or other process improvement methodologies.Ability to use quality tools such as Pareto charts, histograms, statistical process control (SPC), and flowcharts.Familiarity with PFMEA, control plans, measurement system analysis, APQP, and PPAP.Ability to interpret assembly prints and drawings to ensure product and process conformance.Proficient English verbal and written communication skills for effective interaction with cross-functional teams and customers.Familiarity with Microsoft Office (MS) suite, Minitab, or equivalent analytical and reporting software.Assertive communication and decision-making style to drive quality outcomes and influence cross-functional stakeholders.Additional Skills & Qualifications:Experience in a contract manufacturing or electronic manufacturing services (EMS) environment.Exposure to medical device manufacturing quality systems and regulatory frameworks.Working knowledge of IPC standards relevant to electronics and PCB assembly.Experience in continuous improvement initiatives, including Kaizen events and structured CI projects.Ability to coach and train cross-functional teams on quality tools, layered process audits, and best practices.Strong analytical skills for data collection, trend analysis, and process improvement.Comfort working in a KPI-driven environment with measurable quality and operational targets.Demonstrated ability to manage multiple quality projects and initiatives simultaneously.Adaptability to regulatory and standard changes, with the ability to translate requirements into practical process updates.Work Environment:The role operates in a fast-paced, KPI-driven manufacturing environment focused on electronics and medical device production. The Quality Engineer has full ownership of assigned processes and is expected to manage quality activities from the production floor to the QMS level. The work involves frequent interaction with production, engineering, and supplier quality teams, as well as participation in audits and layered process reviews. There will be stress points and time-sensitive situations, particularly around audits, customer issues, and production challenges, requiring resilience, strong prioritization, and clear communication. The environment emphasizes continuous improvement, data-driven decision-making, and accountability for process performance and product quality.Job Type & Location:This is a Permanent position based out of Plano, TX.Pay and Benefits:The pay range for this position is $90000.00 - $110000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Full benefits - health, dental, vision, bonus potentialWorkplace Type:This is a fully onsite position in Plano, TX.Application Deadline:This position is anticipated to close on Sep 11, 2026.